Ország: Málta
Nyelv: angol
Forrás: Medicines Authority
NORETHISTERONE
Bayer PLC
G03DC02
NORETHISTERONE
TABLET
NORETHISTERONE 5 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2007-04-19
PACKAGING TECHNOLOGY BERLIN SGQWX page 1 Bayer AG client: JS86 material-no.: 85996428 PZ: 2598F-4 code-no.: 36 name: LF-PRIMOLUT N 5MG TAB GB country: GB/-/BAG colors: BLACK version: 21.07.2017/01 Restricted Document dimension: 420 X 160 MM THIS AREA MUST BE IDENTICAL ON BOTH SIDES! J PLEASE TURN OVER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT PRIMOLUT N IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRIMOLUT N 3. HOW TO TAKE PRIMOLUT N 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PRIMOLUT N 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT PRIMOLUT N IS AND WHAT IT IS USED FOR Primolut N contains norethisterone, which belongs to a group of medicines called _progestogens_, which are female hormones. Primolut N can be used in several different circumstances: R to treat irregular, painful or heavy periods R to treat endometriosis (where tissue from the lining of the womb is present in places where it is not normally found) R to treat premenstrual syndrome (also known as premenstrual tension, PMS or PMT) R to delay periods 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRIMOLUT N R Your doctor will discuss your medical and family history with you. Your doctor will also need to check your blood pressure and make sure you are not pregnant. You may also need additional checks, such as a breast examination, that will be specific to your medical needs and/or concerns. DO NOT TAKE PRIMOLUT N: R IF YOU ARE ALLERGIC to norethisterone or any of the other ingredients of this medicine (listed in s Olvassa el a teljes dokumentumot
1.3.1 1 v008_0 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Primolut N ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 milligrams of norethisterone BP. Excipient with known effect Lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM. Tablet. White, uncoated tablets impressed with ‘AN’ in a regular hexagon on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Metropathia haemorrhagica. Premenstrual syndrome. Postponement of menstruation. Endometriosis. Menorrhagia. Dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Not intended for use in children. _Metropathia haemorrhagica (dysfunctional uterine bleeding): _1 tablet 3 times daily for 10 days. Bleeding is arrested usually within 1-3 days. A withdrawal bleeding resembling normal menstruation occurs within 2-4 days after discontinuing treatment. One tablet twice daily from the 19 th to the 26 th day of the two subsequent cycles should be given to prevent recurrence of the condition. To ensure treatment success, Primolut N must be taken for the full 10 days. Occasionally, slight bleeding may occur after the initial suspension of bleeding. Treatment should not be interrupted or suspended in these cases. If vaginal bleeding does not stop, despite correct tablet intake, an organic cause or an extra- genital factor (e.g. polyps, carcinoma of the cervix uteri or endometrium, myoma, residua of abortion, extra-uterine pregnancy, or coagulation disorders) must be considered so that other measures are then mostly required. This also applies to cases where after an initial suspension of bleeding, fairly heavy bleeding reoccurs during tablet intake. _Premenstrual syndrome (including premenstrual mastalgia): _ Premenstrual symptoms such as headache, migraine, breast discomfort, water retention, tachycardia, and psychological disturbances may be relieved by the administration of 1-3 tablets daily from the 19 th to the 26 th day of the cycle. Treatment should be repe Olvassa el a teljes dokumentumot